Ametropia treatment tracking methods and system

ABSTRACT

A system, method and computer program product for estimating future axial elongation of an individual&#39;s eye as a way to predict and track refractive error progression of an individual. The method includes: receiving, via a computer interface, data relating to refractive change in a prior pre-determined time period for the individual from a reference timepoint; receiving data representing an age of the individual and data representing a current axial length value of the eye as measured at the reference timepoint; calculating, by said processor, a future axial elongation of the eye as a function of the age of the individual, the current axial length value of the eye as measured at the reference timepoint, and the refractive change in the prior pre-determined time period; generating, an output indication of said computed axial elongation of the eye, and using said output indication to select a myopia control treatment for said individual.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/489,666 filed on Apr. 25, 2017, and is acontinuation-in-part of U.S. patent application Ser. No. 15/007,660filed Jan. 27, 2016.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to methods and a system for determiningmyopia progression in an individual by predicting changes in the axiallength of the individual's eye based on that individual's pastrefractive rate of change, and for recommending a myopia controltreatment option for controlling refractive progression based on thepredicted axial elongation.

Discussion of the Related Art

Common conditions which lead to reduced visual acuity include myopia andhyperopia, for which corrective lenses in the form of spectacles, orrigid or soft contact lenses, are prescribed. The conditions aregenerally described as the imbalance between the length of the eye andthe focus of the optical elements of the eye. Myopic eyes focus light infront of the retinal plane and hyperopic eyes focus light behind theretinal plane. Myopia typically develops because the axial length of theeye grows to be longer than the focal length of the optical componentsof the eye, that is, the eye grows too long. Hyperopia typicallydevelops because the axial length of the eye is too short compared withthe focal length of the optical components of the eye, that is, the eyedoes not grow long enough.

Myopia has a high prevalence rate in many regions of the world. Ofgreatest concern with this condition is its possible progression to highmyopia, for example, greater than five (5) or six (6) diopters, whichdramatically affects one's ability to function without optical aids.High myopia is also associated with an increased risk of retinaldisease, cataract, glaucoma, and myopic macular degeneration (MMD; alsoknown as myopic retinopathy), and may become a leading cause ofpermanent blindness worldwide. For example, MMD has been related torefractive error (RE) to a degree rendering no clear distinction betweenpathological and physiological myopia and such that there is no “safe”level of myopia.

Corrective lenses are used to alter the gross focus of the eye to rendera clearer image at the retinal plane, by shifting the focus from infront of the plane to correct myopia, or from behind the plane tocorrect hyperopia, respectively. However, the corrective approach to theconditions does not address the cause of the condition, but is merelyprosthetic or intended to address symptoms.

Most eyes do not have simple myopia or hyperopia, but have myopicastigmatism or hyperopic astigmatism. Astigmatic errors of focus causethe image of a point source of light to form as two mutuallyperpendicular lines at different focal distances. In the followingdiscussion, the terms myopia and hyperopia are used to include simplemyopia and myopic astigmatism and hyperopia and hyperopic astigmatismrespectively.

Emmetropia describes the state of clear vision where an object atinfinity is in relatively sharp focus without the need for opticalcorrection and with the crystalline lens relaxed. In normal oremmetropic adult eyes, light from both distant and close objects passingthrough the central or paraxial region of the aperture or pupil isfocused by the crystalline lens inside the eye close to the retinalplane where the inverted image is sensed. It is observed, however, thatmost normal eyes exhibit a positive longitudinal spherical aberration,generally in the region of about +0.5 Diopters (D) for a 5 mm aperture,meaning that rays passing through the aperture or pupil at its peripheryare focused +0.5 D in front of the retinal plane when the eye is focusedto infinity. As used herein the measure D is the dioptric power, definedas the reciprocal of the focal distance of a lens or optical system, inmeters.

The spherical aberration of the normal eye is not constant. For example,accommodation (the change in optical power of the eye derived primarilythrough changes to the crystalline lens) causes the spherical aberrationto change from positive to negative.

U.S. Pat. No. 6,045,578 discloses that the addition of positivespherical aberration on a contact lens will reduce or control theprogression of myopia. The method includes changing the sphericalaberration of an ocular system to alter the growth in eye length. Inother words, emmetropization may be regulated by spherical aberration.In this process, the cornea of a myopic eye is fitted with a lens havingincreasing dioptric power away from the lens center. Paraxial light raysentering the central portion of the lens are focused on the retina ofthe eye, producing a clear image of an object. Marginal light raysentering the peripheral portion of the cornea are focused in a planebetween the cornea and the retina, and produce positive sphericalaberration of the image on the latter. This positive sphericalaberration produces a physiological effect on the eye which tends toinhibit growth of the eye, thus mitigating the tendency for the myopiceye to grow longer.

SUMMARY OF INVENTION

A system, method and computer program product for estimating a futureaxial elongation (change of length) of an eye of an individual and usingan axial elongation value as an index of an individual's myopicprogression.

The system is computer implemented and runs computer program productshaving methods to predict an individual's eye growth, i.e., the axialelongation of an individual's eye, based on that individual's pastmyopia progression rate, and particularly, as a function of refractivechange values detected for that individual over a past predeterminedtime period, i.e., a past progression rate (e.g., over a past year) andother parameters.

The present invention thus may be used to determine an estimation of arefractive change of an individual over a past predetermined time anduse this information to be able to predict a value representing a changein axial length of the eye thereby allowing for estimation of myopiaprogression over a future period of time.

These results can help clinicians detect excessive eye growth at anearly age, thereby facilitating decision-making with respect tointerventions for preventing and/or controlling myopia.

In accordance with one aspect of the present invention, acomputer-implemented method for treating myopia of an individual isprovided. The method comprises: receiving, via an interface at acomputer, data relating to refractive change in a prior pre-determinedtime period for the individual from a reference timepoint; receiving,via the interface, data representing an age of the individual and datarepresenting a current axial length value of the eye as measured at thereference timepoint; calculating, by the processor, a future axialelongation of the eye as a function of the age of the individual, thecurrent axial length value of the eye as measured at the referencetimepoint, and the refractive change in the prior pre-determined timeperiod; generating, an output indication of the computed axialelongation of the eye via the interface, and using the output indicationto select a myopia control treatment for the individual.

In one aspect, the computer-implemented method causes receipt at acomputing device of data relating to past refractive changes for theindividual; and calculates, from the past refractive changes data, aprogression rate of change of refractive change for the individual. Thiscomputed rate of change is further annualized to obtain the refractivechange for a past year.

Based on the determined progression rate of change of refractive changesfor the individual over the past year, the computer-implemented methodcalculates a future axial elongation of the eye as a value ΔAL accordingto:

ΔAL=a×RECIPY (D)−b×age+c×axial length−d

wherein a, b and c are respective coefficients; d is a constant value inmm, RECIPY represents the refractive change in Diopters, age representsan individual's age in years, and axial length is in mm.

Based on the computed ΔAL for an individual, the methods implemented mayrecommend an ametropia control treatment, e.g., prescription of use of amyopia control ophthalmic lens, for example, or a myopia control contactlens, specific to that individual.

In accordance with another aspect of the present invention, there isprovided a computer system for treating myopia of an individual. Thesystem comprises: a memory for storing instructions; and a processorcoupled to the memory, said processor running said stored instructionsto: receive, via an interface at the server, data relating to refractivechange in a prior pre-determined time period for the individual from areference timepoint; receive, via the interface, data representing anage of the individual and data representing a current axial length valueof the eye as measured at the reference timepoint; calculate a futureaxial elongation of the eye as a function of the age of the individual,the current axial length value of the eye as measured at the referencetimepoint, and said refractive change in the prior pre-determined timeperiod; generate an output indication of said computed axial elongationof the eye via the interface, and use said output indication to select amyopia control treatment for said individual.

In a further aspect, there is provided a computer program product forperforming operations. The computer program product includes a storagemedium readable by a processing circuit and storing instructions run bythe processing circuit for running a method. The method is the same aslisted above.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following, more particular description of preferredembodiments of the invention, as illustrated in the accompanyingdrawings.

FIG. 1 depicts a computer-implemented system for estimating future axialelongation of an eye of an individual;

FIG. 2 depicts a method employed for suggesting a treatment option formyopia based on an estimated future axial elongation of an individual'seye according to one embodiment.

FIG. 3 shows a representative hardware environment for practicing atleast one embodiment of the present invention.

DETAILED DESCRIPTION OF INVENTION

The present invention relates to methods and a system for tracking anindividual's refractive error progression over time by estimating afuture axial elongation (change of length) of an eye of an individualand using an axial elongation value as an index of an individual'smyopic progression.

In one embodiment, a computer implemented system runs computer programproducts having methods to predict an individual's eye growth, i.e.,axial elongation of an individual's eye, based on that individual's pastmyopia progression rate as a function of refractive change valuesdetected for that individual over a past predetermined time period,i.e., (e.g., over a past year), and other parameters.

In accordance with another exemplary embodiment, the present inventionis directed to a method for estimating future myopic progression basedon a predicted axial elongation of an eye of an individual, providing atreatment option to reduce, retard, eliminate and potentially reverseprogression of myopia in individuals.

FIG. 1 depicts a computer-implemented system for estimating future axialelongation of an eye of an individual and determining a myopia controltreatment. In some aspects, system 100 may include a computing device, amobile device, or a server. In some aspects, computing device 100 mayinclude, for example, personal computers, laptops, tablets, smartdevices, smart phones, or any other similar computing device forreceiving input data; for performing data analysis such as one or moreof the method steps discussed herein, and for outputting data. The inputdata and output data may be stored or saved in at least one database130. The input and/or output data may be accessed by a softwareapplication 170 installed on computer 100 [for example a computer in theoffice of an Eye Care Practitioner (ECP)]; by a downloadable softwareapplication (app) on a smart device 121; or by a secure website 125 orweb link accessible by a computer via network 99. The input and/oroutput data may be displayed on a graphical user interface of a computeror smart device.

In particular, computing system 100 may include one or more hardwareprocessors 152A, 152B, a memory 154, e.g., for storing an operatingsystem and application program instructions, a network interface 156, adisplay device 158, an input device 159, and any other features commonto a computing device. In some aspects, computing system 100 may, forexample, be any computing device that is configured to communicate witha web-site 125 or web- or cloud-based server 120 over a public orprivate communications network 99. Further, as shown as part of system100, historical data pertaining to individuals' refractive changescaptured from clinicians' measurements and including associated myopiacontrol treatments, are obtained and stored in an attached, or a remotememory storage device, e.g., a database 130.

In the embodiment depicted in FIG. 1, processors 152A, 152B may include,for example, a microcontroller, Field Programmable Gate Array (FPGA), orany other processor that is configured to perform various operations.Processors 152A, 152B may be configured to execute instructions asdescribed below. These instructions may be stored, for example, asprogrammed modules in memory storage device 154.

Memory 154 may include, for example, non-transitory computer readablemedia in the form of volatile memory, such as random access memory (RAM)and/or cache memory or others. Memory 154 may include, for example,other removable/non-removable, volatile/non-volatile storage media. Byway of non-limiting examples only, memory 154 may include a portablecomputer diskette, a hard disk, a random access memory (RAM), aread-only memory (ROM), an erasable programmable read-only memory (EPROMor Flash memory), a portable compact disc read-only memory (CD-ROM), anoptical storage device, a magnetic storage device, or any suitablecombination of the foregoing.

Network interface 156 is configured to transmit and receive data orinformation to and from a web-site server 120, e.g., via wired orwireless connections. For example, network interface 156 may utilizewireless technologies and communication protocols such as Bluetooth®,WIFI (e.g., 802.11a/b/g/n), cellular networks (e.g., CDMA, GSM, M2M, and3G/4G/4G LTE), near-field communications systems, satellitecommunications, via a local area network (LAN), via a wide area network(WAN), or any other form of communication that allows computing device100 to transmit information to or receive information from the server120.

Display 158 may include, for example, a computer monitor, television,smart television, a display screen integrated into a personal computingdevice such as, for example, laptops, smart phones, smart watches,virtual reality headsets, smart wearable devices, or any other mechanismfor displaying information to a user. In some aspects, display 158 mayinclude a liquid crystal display (LCD), an e-paper/e-ink display, anorganic LED (OLED) display, or other similar display technologies. Insome aspects, display 158 may be touch-sensitive and may also functionas an input device.

Input device 159 may include, for example, a keyboard, a mouse, atouch-sensitive display, a keypad, a microphone, or other similar inputdevices or any other input devices that may be used alone or together toprovide a user with the capability to interact with the computing device100.

With respect to the ability of computer system 100 for computing achange in axial length of an individual's eye, the system 100 includes:a memory 160 configured to store data relating to a current individual'spast refractive changes/errors, e.g., data received from a clinicianover a defined period of time, e.g., a past year. In one embodiment,this data may be stored in a local memory 160, i.e., local to thecomputer or mobile device system 100, or otherwise, may be retrievedfrom a remote server 120, over a network. The data relating to a currentindividual's past refractive changes may be accessed via a remotenetwork connection for input to a local attached memory storage device160 of system 100.

In one embodiment, the computing system 100 provides a technologyplatform employing programmed processing modules stored in a devicememory 154 that may be run via the processor(s) 152A, 152B to providethe system with abilities for computing future axial elongation lengthof the eye of an individual based on the input set of historicalrefractive change data received for that individual.

In one embodiment, program modules stored in memory 154 may includeoperating system software 170 and a software applications module 175 forrunning the methods herein that may include associated mechanisms suchas APIs (application programming interfaces) for specifying how thevarious software modules interact, web-services, etc. that are employedto control operations used to carry out the change in axial lengthcomputations. One program module 180 stored in device memory 154 mayinclude a “RECIPY” calculator 190 for determining a value (“RECIPY”)representative of a current individual's refractive change in a pasttime period, e.g., one year. From this RECIPY refractive rate of changevalue of the individual, a further program module 190 stored in devicememory 154 may include program code providing the various data andprocessing instructions of an algorithm that is run by the processors topredict a change in axial length (“ΔAL”) value for that individual.Based on the predicted change in axial length (“ΔAL”) value for thatindividual, a further module 195 may be invoked to recommend to aclinician, the individual, or any user, a treatment option(s) such as atype of myopia contact lens, that may be used for inhibiting orpreventing refractive changes or reducing a refractive progression ratefor the individual.

FIG. 2 depicts a computer-implemented method 200 run at system 100 forestimating future axial elongation of an individual's eye and forsuggesting a treatment option for myopic patients based on an estimatedfuture axial elongation of an individual's eye according to oneembodiment. An individual may include children having an approximate ageof 6 to 14. However, the methods herein could also be applied to youngerchildren, older adolescents, or young adults.

In one embodiment, the method at 205 receives data representing therefractive values measured for that individual over a period of time.For example, the system 100 of FIG. 1 receives from the memory datarepresenting the refractive change of an individual over a period oftime. In one example, a period of time may be one or more years prior toa reference time point, e.g., a current day. Further, at 210 the systemof FIG. 1 receives characteristics about the individual including atleast, the age of the individual. At 215, the system 100 receives thecurrent measure of the axial length of the eye. If this data is notavailable, the clinician or ECP may be prompted via a system displayinterface 158 to obtain or take a current measurement of the axiallength of the individual's eye using ultrasonographic, partial coherenceinterferometry, optical low-coherence reflectometry, swept-sourceoptical coherence tomography or other measurement techniques. From thedata representing the refractive values measured for the individual overa period of time, the system invokes the RECIPY calculator module 180 tocompute the rate of refractive change value of an individual over aperiod of time at 220. By annualizing the rate of change, the systemcalculates the “RECIPY” Refractive Error Change In the Previous Year.For example, if refractive error data is known for 2 years prior to thecurrent date and the change in refraction was −2 D, then there would bea RECIPY value of −1 D where D is diopters. Although typically measuredin clinical practice as refractive error change, future progression iscaptured as axial elongation as this parameter is a more sensitivemeasure than refractive error in monitoring progression and is mostrelevant to the development of myopia related changes, such as myopicretinopathy.

While myopia progression may be characterized by an individual'srefractive error change, according to the present embodiment, myopiaprogression is characterized as the change in axial length of theindividual's eye. Continuing to step 225, FIG. 2, the system 100 runsthe change in axial length calculator module 190 for predicting a changein axial length of the individual's eye. Equation 1) below representsthe predicted change in axial length “ΔAL” as a function of theannualized past rate of refractive change “RECIPY” value, age datareceived at step 210, and axial length data at the time of making theprediction received at 215.

ΔAL=f(RECIPY, Age, Axial Length)

specifically,

ΔAL=[a(mm/D)×RECIPY (D)]−b (mm/yr)×age (yrs)]+[c×axial length (mm)]−d(mm)  (1)

where: ΔAL is the estimated axial elongation of the eye, e.g., over the12-month period after the reference timepoint, and is measured inmillimeters, RECIPY is the refractive error change in the prior year (orrelativized amount where refraction data is not specifically availablefor the prior 12-month period) and is measured in diopters D, “age” isthe age of the child in years, and “axial length” is the axial length ofthe eye as measured in mm at the reference timepoint. In one embodiment,coefficient value a=−0.12051+/−0.05162 (mm/D); coefficient valueb=0.03954+/−0.00323 (mm/yr); coefficient value c=0.036819+/−0.001098;and value d=0.35111+/−0.025809 (mm).

It should be understood that, in a further embodiment, equivalent formsof equation 1) for predicting a future axial elongation of the eye as afunction of the prior refractive change, current axial length and age ofthe patient may be implemented. Such a prediction of future refractivechange may receive a past axial elongation measurement as an inputparameter. Such a prediction of future refractive change may also outputa future predicted refractive error change. Further, the form ofequation 1) may be modified to receive additional input parameterscorresponding to other potential predictors of refractive errorprogression including, but not limited to: biometric data of the patientor of the patient's eye, such as corneal radius, anterior chamber depth,lens thickness, lens power, vitreous chamber depth or similar, orbehavioral aspects of the patient, including but not limited to anamount of time engaged in certain activities, including outdooractivity, levels of close work activity (e.g., number of reading hoursper day or week or month or time spent on studying or reading or timespent on digital devices), or information regarding genetic make-up ofthe patient, including but not limited to: a number of myopic parents orsiblings, the refractive status of the patient's parents or siblings,the patient's race, ethnicity, gender, or further parameters includingbut not limited to a geographic location such as country or degree ofurbanization, or any other type of demographic or environmentalvariables considered relevant to refractive progression.

In one embodiment, equation 1) resulted from a model developed topredict the future ΔAL change in refractive progression according todata from control groups in clinical studies. In an example study, 100subjects in the control groups have been followed for 2 years and thesystem obtained cycloplegic autorefraction, and axial length dataavailable at baseline, 12 months and 24 months as well as sex, race andethnicity data for the subjects. The first 12-month data was used asprior history and the second 12-month data was used as futureprogression with the 12-month examination set as the date at which theprediction of progression for the second twelve-month period is made(i.e., the ‘reference’ timepoint). Subjects included in this datasetwere children between 8 and 15 years age (mean ±SD=9.8±1.3 years) withbaseline best-sphere refraction between −0.75 D and −5.00 D andastigmatism less than or equal to 1.00 D. Fifty-one percent of thesubjects were female and 93% were Asian. Only the right eyes of thesubjects were included in the dataset for analysis. The mean (±SD) of“RECIPY” of this dataset was −0.64±0.52 D in refraction change (range:−2.25 to +0.50 D). Axial elongation during the first 12-month period was0.25±0.16 mm (range: −0.18 to 0.65 mm). At the beginning of the 2^(nd)year, the mean±SD of spherical equivalent of cycloplegic autorefractionwas −3.35±1.26 D (range: −1.37 to −6.87 D), and the mean±SD of axiallength was 24.86±0.87 mm (range: 23.07 to 26.78 mm).

Data available included RECIPY, refractive error and axial length at thereference timepoint, sex, ethnicity and axial elongation in the 2^(nd)12-month period. A multivariate analysis was conducted and yieldedequation 1) to relate the variables and obtain:

ΔAL=[−0.12051 (mm/D)×RECIPY (D)]−[0.03954 (mm/yr)×age(yrs)]+[0.036819×axial length (mm)]−0.35111 (mm).

Statistical information on the fits are shown in the Table 1 below whereF and P represents statistical values that determine a statisticalsignificance as derived from conducting an analysis of variance. Basedon the low P values, it is seen that the RECIPY, Age and Axial Lengthare significant predictor values.

TABLE 1 Variable F P RECIPY 19.36 P < 0.0001 Age 12.13 P < 0.001 AxialLength  5.28 P < 0.05

In one embodiment, fast progressors may be considered to have axialelongation above, for example, 0.20 mm. In this case, the equation 1)algorithm exhibits a sensitivity of 0.87 and specificity of 0.58. In oneembodiment, the mean progression in those predicted to be fastprogressors is 0.301 mm/yr by this criterion and was twice that of thosepredicted to be slow progressors (0.146 mm/yr). If a cutoff value fromthe algorithm of 0.23 mm is used to predict those who will progress morethan 0.20 mm, the sensitivity is 0.79 with specificity of 0.71.

Table 2 below shows some selected example predictions for axialelongation in the 2^(nd) year for the given data at the referencetimepoint, i.e., age at reference time point, axial length of thereferent time point, and the determined RECIPY value.

TABLE 2 Predicted Axial Axial Age RECIPY Length Elongation Effect of age7 −0.500 23.5 0.298 8 −0.500 23.5 0.258 9 −0.500 23.5 0.219 12  −0.50023.5 0.100 Effect of RECIPY 8 −0.250 23.5 0.228 8 −0.500 23.5 0.258 8−0.750 23.5 0.288 Effect of axial length 8 −0.500 23.5 0.258 8 −0.50024.5 0.295 8 −0.500 25.5 0.332

Returning to FIG. 2, based on the predicted future ΔAL change inrefractive progression, a specific type of soft lens or orthokeratologytreatment regime may be recommended. In one embodiment, in FIG. 2 at230, the system 100 may determine an optical device such as a softcontact lens having a suitable refraction design for use as myopiatreatment for the individual given the individual's predictedprogression of myopia based on the predicted ΔAL change over the nextyear. In one embodiment, the treatment option may include a multi-focalcontact lens having positive spherical aberration and increasingdioptric power away from the lens center that creates an amount ofperipheral “blur” to deprive the eye of light in a manner as known forinhibiting the eye's growth. In other embodiment, it may be determinedthat a regimen of eye drops or other pharmaceutical treatmentadministered to the individual may be suitable for reducing theprogression of myopia; or a regimen of time spent outdoors may bedetermined to retard or prevent myopia progression. Any treatment optionavailable now or in the future that may reduce, retard, eliminate oreven reverse the progression of myopia in the individual is determinedat 230. At 235, FIG. 2, the system may automatically generate arecommendation for the clinician via system display interface 158whether locally connected to the system or for communication over anetwork to a remote computer.

In one embodiment, the display may be a graphical user interface of thecomputer or a smart device (e.g., a tablet computer, smart phone,personal digital assistant, wearable digital device, gaming device, TV).In a specific embodiment, the display may be synchronized on an Eye Careprovider's computer or smart device and on a user computer or smartdevice.

Fast Progressor Prediction

In one embodiment, system 100 may further identify myopes likely to befast progressors. Detecting of such myopes may be useful for targetingtreatment regimens and in designing myopia control clinical studies. Asit has been showed that history of fast progression is a factor ofsimilar or better predictive value than age, a well-known risk factor,in assessing likelihood of future fast progression, the algorithm ofequation 1) including historical refractive progression (RECIPY) may beused for predicting future fast progression.

In a further example: the system 100 received the Cycloplegicautorefraction (CAR) data and axial length data, (e.g., obtained bypartial interferometry) obtained over a time period including atbaseline, 1 yr and 2 yrs in 100 children aged 8 to 15 years with −0.75to −5.00 D of myopia. A multivariable regression analysis was conductedwith right eye axial elongation during the 2^(nd) yr was fit in themultivariable analysis by refractive error change in the previous year(RECIPY), age, gender, ethnicity, 1 yr axial length and 1 yr refractiveerror. Axial elongation was chosen as the dependent variable because ofits better sensitivity in identifying progression, but past refractivechange was used as a predictive variable.

Example p-value analysis results for RECIPY, age, 1-year axial lengthfactors are: RECIPY (p<0.0001), age (p<0.001), 1 yr axial length(p<0.05) and RECIPY*age interaction (p<0.05) indicating that all thesefactors contributed significantly in predicting axial elongation between1 and 2 yrs. Gender, ethnicity and 1 yr refractive error did notcontribute significantly to predicting of axial elongation. The modelfit accounted for 57% of the variance in axial elongation in the 2^(nd)yr. Using a criterion of 0.2 mm, the model has a sensitivity of 0.87 anda specificity of 0.58 in predicting fast progressors. The meanprogression in those categorized as fast progressors (0.301 mm/yr) bythis criterion was twice that of those predicted to be slow progressors(0.146 mm/yr).

Thus, the computation of ΔAL according to equation 1) provides a goodprediction of future axial elongation. This information is useful inguiding myopia control treatment and in design of clinical studies.

Applicant's co-pending U.S. patent application Ser. No. 15/007,660, thewhole contents and disclosure of which is incorporated by reference asif fully set forth herein, details a system and method for predictingand tracking an individual's refractive error progression over time. Thesystem and method described are applied to optimally determine a courseof treatment for myopia and for an ECP to evaluate over time whether thecourse of treatment applied for the individual has been/maybe effective.ECPs, parents, and patients are thus provided with a betterunderstanding of the possible long-term benefit of a particular myopiacontrol treatment.

Based on the system, methods, and computer program products, the presentinvention may assist an ECP to choose a type of myopia control treatmentand/or ophthalmic lens for a child based on the computed future axialelongation of the eye and a resulting anticipated progression of myopia.

The methods described in co-pending U.S. patent application Ser. No.15/007,660 system may be implemented for ECPs to demonstrate and trackthe effectiveness of treatments to slow the progression of myopia andallow individuals to understand the long-term benefit of a myopiacontrol treatment. The principles described in co-pending U.S. patentapplication Ser. No. 15/007,660 may be applied to track myopia controltreatments to slow the progression of myopia based on the determining ofthe predicted axial elongation values according to equation 1).

Thus, the tracking methods and system to estimate a potential axialelongation of an individual's eye over a future predetermined period oftime relative to a reference population, may be used to: 1) allow ECPsto predict and track axial elongation (and hence, refractive)progression as well as demonstrate and track the effectiveness oftreatments to slow the progression of myopia and/or 2) allow patients orparents to understand the long-term benefit of a myopia controltreatment.

While the principles discussed herein are directed to myopia, thepresent invention is not so limited and could be applied to otherrefractive errors, such as hyperopia or astigmatism.

As will be appreciated by one skilled in the art based on thisdisclosure, aspects of the present invention may be embodied as asystem, method, or computer program product. Accordingly, aspects of thepresent invention may take the form of an entirely hardware embodiment,a processor operating with software embodiment (including firmware,resident software, micro-code, etc.) or an embodiment combining softwareand hardware aspects that may all generally be referred to herein as a“circuit,” “module” or “system.” Furthermore, aspects of the presentinvention may take the form of a computer program product embodied inone or more computer readable medium(s) having computer readable programcode embodied thereon.

Any combination of one or more computer readable medium(s) may beutilized. The computer readable medium may be a computer readable signalmedium or a computer readable storage medium. A computer readablestorage medium may be, for example, but not limited to, an electronic,magnetic, optical, electromagnetic, infrared, or semiconductor system,apparatus, or device, or any suitable combination of the foregoing. Morespecific examples (a non-exhaustive list) of the computer readablestorage medium would include the following: an electrical connectionhaving one or more wires, a portable computer diskette, a hard disk, arandom access memory (RAM), a read-only memory (ROM), an erasableprogrammable read-only memory (EPROM or Flash memory), an optical fiber,a portable compact disc read-only memory (CD-ROM), an optical storagedevice, a magnetic storage device, or any suitable combination of theforegoing. In the context of this disclosure, a computer readablestorage medium may be any tangible medium that can contain, or store aprogram for use by or in connection with an instruction executionsystem, apparatus, or device.

Computer program code for carrying out operations for aspects of thepresent invention may be written in any combination of one or moreprogramming languages, including an object-oriented programming languagesuch as Java, Smalltalk, C++, C#, Transact-SQL, XML, PHP or the like andconventional procedural programming languages, such as the “C”programming language or similar programming languages. The program codemay execute entirely on the user's computer, partly on the user'scomputer, as a stand-alone software package, partly on the user'scomputer and partly on a remote computer or entirely on the remotecomputer or server. In the latter scenario, the remote computer may beconnected to the user's computer through any type of network, includinga local area network (LAN) or a wide area network (WAN), or theconnection may be made to an external computer (for example, through theInternet using an Internet Service Provider).

Computer program instructions may be provided to a processor of ageneral-purpose computer, special purpose computer, or otherprogrammable data processing apparatus to produce a machine, such thatthe instructions, which execute with the processor of the computer orother programmable data processing apparatus, create means forimplementing the functions/acts specified.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the functions/acts specified.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified.

Referring now to FIG. 3, a representative hardware environment forpracticing at least one embodiment of the invention is depicted. Thisschematic drawing illustrates a hardware configuration of an informationhandling/computer system in accordance with at least one embodiment ofthe invention. The system comprises at least one processor or centralprocessing unit (CPU) 10. The CPUs 10 are interconnected with system bus12 to various devices such as a random access memory (RAM) 14, read-onlymemory (ROM) 16, and an input/output (I/O) adapter 18. The I/O adapter18 can connect to peripheral devices, such as disk units 11 and tapedrives 13, or other program storage devices that are readable by thesystem. The system can read the inventive instructions on the programstorage devices and follow these instructions to execute the methodologyof at least one embodiment of the invention. The system further includesa user interface adapter 19 that connects a keyboard 15, mouse 17,speaker 24, microphone 22, and/or other user interface devices such as atouch screen device (not shown) to the bus 12 to gather user input.Additionally, a communication adapter 20 connects the bus 12 to a dataprocessing network 25, and a display adapter 21 connects the bus 12 to adisplay device 23 which may be embodied as an output device such as amonitor, printer, or transmitter, for example.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the root terms “include”and/or “have”, when used in this specification, specify the presence ofstated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof.

As used herein, “in communication” includes physical and wirelessconnections that are indirect through one or more additional components(or over a network) or directly between the two components described asbeing in communication.

Although shown and described is what is believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific designs and methods described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. The present invention is notrestricted to the particular constructions described and illustrated,but should be constructed to cohere with all modifications that may fallwithin the scope of the appended claims.

What is claimed is:
 1. A computer-implemented method for treating myopiaof an individual comprising: receiving, via an interface at a computer,data relating to refractive change in a prior pre-determined time periodfor the individual from a reference timepoint; receiving, via theinterface, data representing an age of the individual and datarepresenting a current axial length value of the eye as measured at thereference timepoint; predicting, by said processor, a future axialelongation of the eye as a function of the age of the individual, thecurrent axial length value of the eye as measured at the referencetimepoint, and said refractive change in the prior pre-determined timeperiod; generating, an output indication of said predicted future axialelongation of the eye via the interface, and using said outputindication to select a myopia control treatment for said individual. 2.The computer-implemented method of claim 1, further comprising:receiving data relating to past refractive changes for the individual;and calculating, from said past refractive changes data, a progressionrate of change of refractive changes for the individual; and annualizingthe computed rate of change to obtain the refractive change for a pastyear.
 3. The computer-implemented method of claim 1, wherein said myopiacontrol treatment comprises a myopia control ophthalmic lens, anorthokeratology or a pharmaceutical treatment regime.
 4. Thecomputer-implemented method of claim 1, wherein the myopia controlophthalmic lens comprises a myopia control contact lens.
 5. Thecomputer-implemented method of claim 1, further comprising: comparing,by said processor, the calculated future axial elongation of the eyeagainst a predetermined threshold value; and said processor identifyingan individual to be a fast progressor when said calculated axialelongation of the eye is greater than said predetermined thresholdvalue.
 6. The computer-implemented method of claim 5, wherein saidpredetermined threshold value is about 0.301 mm/yr.
 7. Thecomputer-implemented method of claim 2, wherein said calculated axialelongation of the eye is a value ΔAL, said method comprising calculatingΔAL according to:ΔAL=a×RECIPY (D)−b×age+c×axial length−d wherein a, b and c arerespective coefficients; d is a constant value in mm, RECIPY representssaid refractive change in Diopters (D), age represents an individual'sage in years, and axial length is in mm.
 8. The computer-implementedmethod of claim 7, wherein a=−0.12051+/−0.05162 (mm/D); coefficientvalue b=0.03954+/−0.00323 (mm/yr); coefficient valuec=0.036819+/−0.001098; and value d=0.35111 (mm)+/−0.025809.
 9. Acomputer system for treating myopia of an individual comprising: amemory for storing instructions; and a processor coupled to the memory,said processor running said stored instructions to: receive, via aninterface at the server, data relating to refractive change in a priorpre-determined time period for the individual from a referencetimepoint; receive, via the interface, data representing an age of theindividual and data representing a current axial length value of the eyeas measured at the reference timepoint; predict a future axialelongation of the eye as a function of the age of the individual, thecurrent axial length value of the eye as measured at the referencetimepoint, and said refractive change in the prior pre-determined timeperiod; generate an output indication of said predicted future axialelongation of the eye via the interface, and use said output indicationto select a myopia control treatment for said individual.
 10. Thecomputer system of claim 9, wherein the stored instructions furtherconfigure the processor to: receive data relating to past refractivechanges for the individual; and calculate, from said past refractivechanges data, a progression rate of change of refractive changes for theindividual; and annualize the computed rate of change to obtain therefractive change for a past year.
 11. The computer system of claim 9,wherein said myopia control treatment comprises one or more of: a myopiacontrol ophthalmic lens, a myopia control contact lens, and a softcontact lens, an orthokeratology or a pharmaceutical treatment regime.12. The computer system of claim 9, wherein said processor runs furtherinstructions to: compare the calculated axial elongation of the eyeagainst a predetermined threshold value; and identify an individual tobe a fast progressor when said calculated axial elongation of the eye isgreater than said predetermined threshold value; and select a myopiacontrol treatment for said fast progressor.
 13. The computer system ofclaim 9, wherein said calculated axial elongation of the eye is a valueΔAL, said processor running further instructions to: calculate ΔALaccording to:ΔAL=a×RECIPY (D)−b×age+c×axial length−d wherein a, b and c arerespective coefficients; d is a constant value in mm, RECIPY representssaid refractive change in Diopters, age represents an individual's agein years, and axial length is in mm.
 14. The computer system of claim13, wherein a=−0.12051+/−0.05162 (mm/D); coefficient valueb=0.03954+/−0.00323 (mm/yr); coefficient value c=0.036819+/−0.001098;and value d=0.35111 (mm)+/−0.025809.
 15. A computer program product fortreating myopia of an individual, the computer program productcomprising a non-transitory computer readable storage medium havingprogram instructions embodied therewith, the program instructionsexecutable by a processor to perform a method comprising: receiving, viaan interface at a computer, data relating to refractive change in aprior pre-determined time period for the individual from a referencetimepoint; receiving, via the interface, data representing an age of theindividual and data representing a current axial length value of the eyeas measured at the reference timepoint; predicting, by said processor, afuture axial elongation of the eye as a function of the age of theindividual, the current axial length value of the eye as measured at thereference timepoint, and said refractive change in the priorpre-determined time period; and generating, an output indication of saidpredicted future axial elongation of the eye via the interface, andusing said output indication to select a myopia control treatment forsaid individual.
 16. The computer program product of claim 15, whereinsaid program instructions further configure said processor to perform:receiving data relating to past refractive changes for the individual;and calculating, from said past refractive changes data, a progressionrate of change of refractive changes for the individual; and annualizingthe computed rate of change to obtain the refractive change for a pastyear.
 17. The computer program product of claim 15, wherein said myopiacontrol treatment comprises a myopia control ophthalmic lens, anorthokeratology or a pharmaceutical treatment regime.
 18. The computerprogram product of claim 15, wherein the myopia control ophthalmic lenscomprises a myopia control contact lens.
 19. The computer programproduct of claim 15, wherein said computed said axial elongation of theeye is a value ΔAL, said method comprising calculating ΔAL according to:ΔAL=a×RECIPY (D)−b×age+c×axial length−d wherein a, b and c arerespective coefficients; d is a constant value in mm, RECIPY representssaid refractive change in Diopters, age represents an individual's agein years, and axial length is in mm.
 20. The computer program product ofclaim 19, wherein a=−0.12051+/−0.05162 (mm/D); coefficient valueb=0.03954+/−0.00323 (mm/yr); coefficient value c=0.036819+/−0.001098;and value d=0.35111 (mm)+/−0.025809.